Healthy Nutrition and Energy Restriction as Cancer Prevention Strategies: a Randomized Controlled Intervention Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Changes in gene expression in subcutaneous adipose tissue measured by whole genome sequencing
研究概览
简要总结
This study evaluates the effect of intermittent calorie restriction versus continued calorie restriction on weight loss, gene expression profile of subcutaneous adipose tissue and abdominal fat distribution.
详细描述
Since obesity has become a major public health concern appropriate strategies are needed in order to reduce obesity-related health risks in later life span. Obesity is one of the main risk factors not only for diabetes and cardiovascular diseases, but also for several types of cancer. Several key mechanisms, which may link obesity, metabolic dysregulation and cancer risk, such as obesity-driven inflammation, altered adipokine, growth factor and sex hormone signaling, and changes in the microbiota have been identified.
Various studies have shown that continuous calorie restriction (CCR) and exercise are effective strategies to enforce weight-loss and improve biomarker profiles. Intermittent calorie restriction (ICR) as a novel strategy might induce favorable metabolic changes and lead to higher compliance rates. The concept of this diet regime is very simple e.g. 2 days/week of fasting following a standardized diet covering 25 % of energy needs and 5 days/week of ad libitum consumption. To verify the effectiveness of ICR as an alternative weight loss strategy to CCR controlled intervention trials are required. Although both CCR and ICR induce a negative energy balance, the metabolic effect on human physiology might differ.
Within the HELENA-study 50 non-smoking adults (men and women aged 35 to 65 years) with an BMI ≥ 25 kg/m² and ≤ 40 kg/m² will be randomly assigned to each of the intervention arms: (1) ICR arm (2 day/week fasting, i.e. 25% energy intake, energy intake of 100% on 5 days/week leading to a weekly average energy intake of ~80%) (2) CCR arm (daily energy intake of 80%) and 3) control arm (general advice on healthy nutrition).
The trial will last 1 year, with an intervention phase of 12 weeks (weeks 0-12; intervention; close contact with participants), followed by a maintenance phase (weeks 13-24; maintenance; regular, but less frequent contact with participants) and a follow-up phase (weeks 25-52).
Biological specimens will be collected as follows:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Women and men aged 35 to 65 years
- •Overweight or obese (BMI ≥ 25 kg/m2 ≤ 40 kg/m2 )
- •German speaking
- •Non- smoker
- •Provision of written informed consent
排除标准
- •Not able to understand and sign the informed consent form in person
- •Already diagnosed diabetes
- •HbA1c ≥ 6.5 % and/or fasting plasma glucose > 125 mg/dl
- •History of cancer within the past 10 years
- •Risk of bleeding disorders (e.g. Marcumar intake)
- •Current or history of eating disorders (bulimia, anorexia, binge-eating)
- •Pregnant or lactating during the past 12 months
- •Increased or decreased thyroid-stimulating hormone in baseline blood check
- •Already diagnosed hepatic dysfunction and/or increased or decreased γ-GT, GPT and/or GOT in baseline blood check
- •Already diagnosed kidney dysfunction and/or increased or decreased creatinine, urea and/or uric acid in baseline blood check
- •Medications that might affect the endpoints of the study e.g. immunosuppressive medication (cortisol, antibody treatment), hormone replacement therapy, medication for fat metabolism (e.g. statine, fibrate)
- •Participation in another intervention study shorter than three months ago
结局指标
主要结局
Changes in gene expression in subcutaneous adipose tissue measured by whole genome sequencing
时间窗: Assessments at baseline (week 0), and after the intervention phase (week 13)
次要结局
- Changes in weight (kg)(Assessments at baseline (week 0), after the intervention phase (week 13), after the maintencance phase (week 25) and after the follow-up phase (week 52))
- Changes in abdominal fat distribution pattern (visceral, subcutaneous, total adipose tissue) measured by magnetic resonance spectroscopy(Assessments at baseline (week 0), after the intervention phase (week 13),and after the follow-up phase (week 52))
- Changes in BMI (kg/m2)(Assessments at baseline (week 0), after the intervention phase (week 13), after the maintencance phase (week 25) and after the follow-up phase (week 52))
- Changes in liver fat content measured by magnetic resonance spectroscopy(Assessments at baseline (week 0), after the intervention phase (week 13),and after the follow-up phase (week 52))
- Changes in blood-based biomarkers, i.e. parameters of inflammation, adipokines, growth and hormonal factors, which have been shown to be associated with obesity-related chronic diseases before(Assessments at baseline (week 0), after the intervention phase (week 13), after the maintenance phase (week 25), and after the maintenance phase (week 25))
- Changes in hip circumference (cm)(Assessments at baseline (week 0), after the intervention phase (week 13), after the maintencance phase (week 25) and after the follow-up phase (week 52))
- Changes in pulse (bpm)(Assessments at baseline (week 0), after the intervention phase (week 13), after the maintencance phase (week 25) and after the follow-up phase (week 52))
- Changes in waist circumference (cm)(Assessments at baseline (week 0), after the intervention phase (week 13), after the maintencance phase (week 25) and after the follow-up phase (week 52))
- Changes in blood pressure (mm/Hg)(Assessments at baseline (week 0), after the intervention phase (week 13), after the maintencance phase (week 25) and after the follow-up phase (week 52))
- Changes in quality of life (as defined by changes in SF-12-derived scores)(Assessments at baseline (week 0) and after the intervention phase (week 13))
研究者
Tilman Kuehn
Dr. Tilman Kühn
German Cancer Research Center